An interventional study of harmony in Stress, Self Efficacy and Resilience, Psychological, sponsored by University of Witten/Herdecke. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-24.
Sponsored by University of Witten/Herdecke · Not applicable, Interventional, and Prevention
The purpose of this study is to investigate the efficacy of app-based stress prevention via the harmony application in a prospective, interventive, monocentric, explanatory pilot randomized controlled trial (RCT), with participants' subjective stress experience as the primary endpoint.
Research question: Does usage of the app harmony have a positive impact on the subjective experience of stress of its users? Do usage frequency, intensity or width of content engagement influence the efficacy of the intervention?
Hypothesis: We expect improvement of participants' subjective stress experience, stress-related symptoms, subjective well-being, resilient coping, self-efficacy, life satisfaction and goal-attainment.
2,193 studies on the registry are indexed under Psychological Well-Being; 728 are open to participants now.
This study's enrollment of 251 is above the median of 110 across 1,796 interventional studies indexed under Psychological Well-Being.
Browse Psychological Well-Being studies →University of Witten/Herdecke is the lead sponsor of 40 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Use of the harmony application, with 6- and 12-week follow-up. Measurements will be taken at baseline as well as at 6- and 12-week follow-up.
Behavioral: harmony
Use of the harmony application after a 12-week waiting period. Measurements will be taken at baseline as well as at 6- and 12-week follow-up.
Use of the app-based digital self-help intervention harmony over a 12-week-period. The app was designed for stress management and the preventive promotion of mental health. Harmony provides users with access to a wide range of psychological self-help content, including video episodes, audio sessions, texts, and downloadable materials. Utilizing artificial intelligence, Harmony offers personalized content suggestions tailored to the user's individual situation and preferences, ensuring the content remains relevant and updated. Content is delivered through a combination of psychoeducation, guided exercises, relaxation techniques, meditations, practical tasks, self-reflection activities, and everyday application tasks.
Change from baseline stress at 6 weeks and 12 months
Perceived Stress Scale (PSS-10, Cohen et al., 1983): Self-report measure to assess psychological stress levels; Likert scale: 1 = never, 5 = very often.
Time frame: Baseline, 6-week follow-up, 12-week follow-up
Change from baseline stress symptoms at 6 weeks and 12 months
Stress and Coping Inventory (SCI; Satow, 2024): Self-report measure to assess psychological and physical stress symptoms; Likert scale: 1 = completely true (negative), 4 = not true at all (positive)
Time frame: Baseline, 6-week follow-up, 12-week follow-up
Subjective well-being
WHO-5 Well-Being Index (WHO-5; WHO, 1998): Self-report measure to assess subjective well-being. Likert scale from 0 = at no time to 5 = all of the time.
Time frame: Baseline, 6-week follow-up, 12-week follow-up
Resilient coping
Brief resilient coping scale (BRCS; Kocalevent et al., 2014): Self-report measure to assess an individual's ability to cope with stress in a resilient manner. Likert scale from 1 = describes me not at all to 5 = describes me very well.
Time frame: Baseline, 6-week follow-up, 12-week follow-up
Self-efficacy
General Self-Efficacy Scale (GSE-SI; Di et al., 2023): One-item self-report measure to assess an individual's belief in their ability to perform tasks and handle situations effectively across a variety of contexts.
Time frame: Baseline, 6-week follow-up, 12-week follow-up
Life satisfaction
Life Satisfaction Scale (L-1; Beierlein et al., 2015): One-item self-report measure to assess a person's subjective evaluation of their quality of life. Likert scale from 1 = not satisfied at all to 11 = completely satisfied.
Time frame: Baseline, 6-week follow-up, 12-week follow-up
Goal Attainment
Goal Attainment Scaling (GAS; Grosse Holtforth \& Grawe, 2002): Self-report measure to assess participants' previously set goals and their achievement; Scale from 0% to 100% in steps of 10%
Time frame: Baseline, 6-week follow-up, 12-week follow-up
Experience in Social Systems (EXIS; Hunger et al., 2017)
Self-report measure to assess systemic functioning in private and organizational social systems; Likert scale: 1 = not at all (negative), 6 = fully (positive)
Time frame: Baseline, 6-week follow-up, 12-week follow-up
Frequency of application use
Participants' self report on absolut app usage over the past 6 weeks in days.
Time frame: 6-week follow-up, 12-week follow-up (experiment group only)
Duration of application use
Participants' self report on average app usage in minutes per session.
Time frame: 6-week follow-up, 12-week follow-up (experiment group only)
Extent of application use
Participants' self report on the extent of usage of different features within the app over the past six weeks. Respondents are asked to indicate which of the following functions they have used: Video, meditation, resilience course, texts, downloadable materials, and mental health checkup. Additionally, respondents specify the frequency of usage for each function.
Time frame: 6-week follow-up, 12-week follow-up (experiment group only)
User experience
Participants' self-report on overall impressions of the app. Likert scale from 1 = don't agree at all to 5 = completely agree
Time frame: 6-week follow-up, 12-week follow-up (experiment group only)
User satisfaction
Participants' self report on overall satisfaction with their experience using the app. Likert scale from 1 = very bad to 5 = very good
Time frame: 6-week follow-up, 12-week follow-up (experiment group only)
Plan to share: No
Ran from Nov 2024 to primary completion in Mar 2025, 3 months.
Of 1,259 non-industry interventional studies with no phase under Psychological Well-Being, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 34. This study's 3 months is below that.
Counting every sponsor, half of 1,302 studies reached it within 16 months; a quarter within 7 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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University of Witten/Herdecke